Advertisement

Topics

Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops

2014-08-27 03:18:59 | BioPortfolio

Summary

The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.

Description

The purpose of this study is to evaluate the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporarily occlude blood vessels while forming an anastomosis. LeGoo™ will be evaluated in subjects undergoing off-pump coronary artery by-pass (OPCAB) surgery. This is a prospective, randomized trial with a 30-day follow-up period. Half of the eligible patients will be randomized to the experimental group (LeGoo™); and the other half to the control group (standard vessel loops).

LeGoo™ is polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGoo™ is injected into a blood vessel that is intended to be occluded, where it stays in a "plug" form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer can never re-solidify.

The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.

Satisfactory hemostasis is defined by the surgeon who will quantitate his/her observation about the quality of the surgical field using the following scoring system:

1. - Excellent hemostasis (no bleeding)

2. - Minimal bleeding (bleeding does not interfere with suturing)

3. - Modest bleeding (required intermittent use of another device to control bleeding at the site of the anastomosis)

4. - Copious bleeding (required continuous use of another device)

"Excellent hemostasis" and "minimal bleeding" are considered "satisfactory hemostasis." Satisfactory hemostasis will constitute a treatment success for the purpose of evaluating the primary efficacy of LeGoo. The primary endpoint is the proportion of anastomoses in which satisfactory hemostasis is achieved.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Off Pump Coronary Artery Bypass Surgery

Intervention

LeGoo, Control

Location

Klinik fur Herzchirurgie Herzzentrum Leipzig
Leipzig
Germany

Status

Recruiting

Source

Pluromed, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:59-0400

Clinical Trials [4015 Associated Clinical Trials listed on BioPortfolio]

SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at...

German Off Pump Coronary Artery Bypass in Elderly Study

Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old. Hypothesis: The coronary bypass...

Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in FY 1999. Thro...

Tranexamic Acid in Off-pump Coronary Surgery

The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bl...

Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.

The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass...

PubMed Articles [20556 Associated PubMed Articles listed on BioPortfolio]

Costs Five Years after Off-Pump or On-pump Coronary Artery Bypass Surgery.

Coronary artery bypass surgery (CABG) is a common surgical treatment for ischemic heart disease. Little is known about the long-term costs of conducting the surgery on-pump or off-pump.

Off-Pump versus On-Pump Impact: Diabetic Patient Five-Year Coronary Artery Bypass Clinical Outcomes.

For diabetic patients requiring coronary artery bypass graft (CABG) surgery, controversy persists whether an off-pump or an on-pump approach may be advantageous. As the first US-based, multi-center, r...

Current Status of Off-pump Coronary Artery Bypass Grafting in Patients with Multiple Coronary Artery Disease Compared with On-pump Coronary Artery Bypass Grafting: The Korean National Cohort Study.

 Despite advance in off-pump coronary artery bypass (OPCAB) grafting, there are large debating issues regarding survival benefit between OPCAB and on-pump coronary artery bypass grafting (CABG). The...

Hemodynamic Changes During Heart Displacement in Aorta No-Touch Off-Pump Coronary Artery Bypass Surgery: A Pilot Study.

To evaluate the sequential changes of hemodynamic and metabolic parameters in patients who underwent aorta no-touch off-pump coronary artery bypass surgery (OPCAB).

Mid- and long-term prognosis of off- vs. on-pump coronary artery bypass graft in patients with multisite artery disease.

Among patients with coronary artery disease (CAD), around 25% have multisite artery disease (MSAD). Patients with CAD and MSAD are at higher risk of peri-operative and long-term cardiovascular events....

Medical and Biotech [MESH] Definitions

Coronary artery bypass surgery on a beating HEART without a CARDIOPULMONARY BYPASS (diverting the flow of blood from the heart and lungs through an oxygenator).

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.

Abdominal artery that follows the curvature of the stomach. The right gastroepiploic artery is frequently used in CORONARY ARTERY BYPASS GRAFTING; MYOCARDIAL REVASCULARIZATION, and other vascular reconstruction.

A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.

More From BioPortfolio on "Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial